US9271904B2ExpiredUtilityA1

Controlled release oral delivery systems

79
Assignee: GEBRESELASSIE PETROSPriority: Nov 21, 2003Filed: May 23, 2005Granted: Mar 1, 2016
Est. expiryNov 21, 2023(expired)· nominal 20-yr term from priority
A61K 9/0058A61K 8/602A61K 9/2081A23G 4/20A61K 8/42A61K 8/8135A61Q 11/00A61K 9/1623A61K 9/1617A23G 4/12A23G 4/064A61K 2800/412A23L 27/74A61K 8/361A61K 9/1635A61K 8/22A61K 8/11A61K 8/55A23L 1/22025
79
PatentIndex Score
2
Cited by
345
References
26
Claims

Abstract

Oral delivery systems including at least one encapsulated active are provided. The oral delivery systems include at least one active component; and a polymer matrix at least partially encapsulating the at least one active component. In some embodiments, the polymer matrix has a tensile strength of at least about 6,500 psi and/or includes at least one polymer having a water absorption of about 0.01% to about 50% by weight. The at least one active component may be an oral care active, which may be encapsulated alone or in combination with other actives, such as a taste masking active.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. An oral delivery system comprising:
 at least one active component; wherein the at least one active component is an anticalculus agent is selected from the group consisting of pyrophosphates, triphosphates, polyphosphates, polyphosphonates and combinations thereof; and 
 a polymer matrix at least partially encapsulating said at least one active component, said polymer matrix having a tensile strength of at least 6,500 psi and comprising at least one polymer having a water absorption of about 0.1% to about 15% by weight as measurable by ASTM D570-98 and hydrogenated oil; wherein the polymer is selected from the group consisting of polyvinyl acetate, polyvinyl acetatephthalate, polymethylmethacrylate, polyethylene terephthalate and combinations thereof. 
 
     
     
       2. The system of  claim 1 , wherein the delivery system, when used in an oral composition, releases a controlled amount of the active component in an oral cavity over a longer period of time as compared to an oral composition wherein the active component is free. 
     
     
       3. The system of  claim 2 , wherein the period of time is about 5 to about 60 minutes. 
     
     
       4. The system of  claim 3 , wherein at least 50% of the active component remains in the oral composition after the time period of about 5 to about 60 minutes. 
     
     
       5. The system of  claim 1 , wherein the polymer matrix has a tensile strength of about 20,000 to about 50,000 psi. 
     
     
       6. The system of  claim 1 , wherein the anticalculus agent is sodium hexametaphosphate. 
     
     
       7. The system of  claim 1 , wherein the anticalculus agent is sodium tripolyphosphate. 
     
     
       8. An oral composition comprising the oral delivery system of  claim 1 . 
     
     
       9. The oral composition of  claim 8 , further comprising a carrier composition selected from the group consisting of a gum base, a confectionary base, a toothpaste base, a gel dentifrice base and a tooth powder base. 
     
     
       10. The oral composition of  claim 9 , wherein the composition is a gum composition. 
     
     
       11. A gum composition comprising:
 (a) a gum base; and 
 (b) a delivery system, said delivery system comprising (i) at least one active component; and (ii) a polymer matrix at least partially encapsulating said at least one active component, said polymer matrix having a tensile strength of at least 6,500 psi and comprising at least one polymer having a water absorption of about 0.1% to about 15% by weight as measurable by ASTM D570-98 and hydrogenated oil; wherein the at least one active component is an anticalculus agent is selected from the group consisting of pyrophosphates, triphosphates, polyphosphates, polyphosphonates and combinations thereof; and wherein the polymer is selected from the group consisting of polyvinyl acetate, polyvinyl acetatephthalate, polymethylmethacrylate, polyethylene terephthalate and combinations thereof. 
 
     
     
       12. The gum composition of  claim 11 , wherein the polymer matrix has a tensile strength of about 20,000 to about 50,000 psi. 
     
     
       13. A method for preparing an oral delivery system, the method comprising:
 at least partially encapsulating at least one active component, wherein the at least one active component is an anticalculus agent is selected from the group consisting of pyrophosphates, triphosphates, polyphosphates, polyphosphonates and combinations thereof in a polymer matrix, thereby forming an oral delivery system, said polymer matrix having a tensile strength of at least 6,500 psi and comprising at least one polymer having a water absorption of about 0.1% to about 15% by weight as measurable by ASTM D570-98 and hydrogenated oil; wherein the polymer is selected from the group consisting of polyvinyl acetate, polyvinyl acetatephthalate, polymethylmethacrylate, polyethylene terephthalate and combinations thereof. 
 
     
     
       14. The method of  claim 13 , wherein the polymer matrix has a tensile strength of about 20,000 to about 50,000 psi. 
     
     
       15. A method for preparing an oral composition comprising:
 providing an oral delivery system, said system comprising (i) at least one active component; wherein the at least one active component is an anticalculus agent is selected from the group consisting of pyrophosphates, triphosphates, polyphosphates, polyphosphonates and combinations thereof; and (ii) a polymer matrix at least partially encapsulating said at least one active component, said polymer matrix having a tensile strength of at least 6,500 psi and comprising at least one polymer having a water absorption of about 0.1% to about 15% by weight as measurable by ASTM D570-98 and hydrogenated oil; wherein the polymer is selected from the group consisting of polyvinyl acetate, polyvinyl acetatephthalate, polymethylmethacrylate, polyethylene terephthalate and combinations thereof; and 
 combining the oral delivery system with a carrier composition. 
 
     
     
       16. The method of  claim 15 , wherein the carrier composition is selected from the group consisting of a gum base, a confectionary base, a toothpaste base, a gel dentifrice base and a tooth powder base. 
     
     
       17. A method for preparing a gum composition, the method comprising:
 at least partially encapsulating at least one active component; wherein the at least one active component is an anticalculus agent is selected from the group consisting of pyrophosphates, triphosphates, polyphosphates, polyphosphonates and combinations thereof, in a polymer matrix, said polymer matrix having a tensile strength of at least about 6,500 psi and comprising at least one polymer having a water absorption of about 0.1% to about 15% by weight as measurable by ASTM D570-98 and hydrogenated oil; wherein the polymer is selected from the group consisting of polyvinyl acetate, polyvinyl acetatephthalate, polymethylmethacrylate, polyethylene terephthalate and combinations thereof; 
 heating a gum base to soften the base; 
 mixing the softened gum base with the at least partially encapsulated active component to obtain a substantially homogeneous mixture; 
 cooling the mixture; and 
 forming the cooled mixture into gum pieces. 
 
     
     
       18. A method of controlling the release of an active component from an oral delivery system comprising:
 providing the oral delivery system of  claim 1 ; 
 employing the oral delivery system in an oral cavity, whereby a controlled amount of the at least one active component is released into the oral cavity. 
 
     
     
       19. The method of  claim 18 , wherein the oral delivery system is present in a gum, the controlled amount of the at least one active component being released into the oral cavity upon mastication of the gum. 
     
     
       20. The oral delivery system of  claim 1 , which is made by melting the polymer in a mixer, adding a hydrogenated oil to the mixer, and adding the at least one active component to the mixer, mixing the polymer, the hydrogenated oil, and the at least one active component in the mixer to form a polymer matrix at least partially encapsulating the at least one active component. 
     
     
       21. The oral delivery system of  claim 20 , wherein the mixer is an extruder. 
     
     
       22. The system of  claim 1  wherein the at least one active component is a dialkali metal pyrophosphate salt, a tetra alkali polyphosphate salt, or a combination thereof. 
     
     
       23. The system of  claim 1  wherein the at least one active component is selected from the group consisting of tetrasodium pyrophosphate, sodium tripolyphosphate, sodium hexametaphosphate, and combinations thereof. 
     
     
       24. The system of  claim 1 , wherein said polymer is polyvinyl acetate. 
     
     
       25. The system of  claim 1 , wherein said system additionally contains a taste masking agent. 
     
     
       26. The system of  claim 1 , wherein the polymer matrix fully encapsulates the at least one active component.

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